Principal Biostatistician

Job Summary

A company is looking for a Principal Biostatistician to provide high-level consulting services for statistical analysis and reporting in clinical trials.

Key Responsibilities

• Provide consulting for statistical activities related to clinical trials and fulfill the responsibilities of study statistician as required
• Develop, review, and finalize statistical analysis plans while validating programming deliverables
• Collaborate with team members for regulatory reviews and support data analyses for trial-specific deliverables

Required Qualifications

• Master's degree in Statistics, Biostatistics, or equivalent work experience preferred
• 5+ years of experience in the Pharmaceutical/Biotechnology industry or equivalent statistical consulting and SAS programming role preferred
• Strong knowledge of ICH guidelines, GCP, and 21 CFR Part 11
• Experience in developing statistical analysis reports and conducting statistical analyses for various trial-level deliverables
• SAS certification is preferred